Investors in MSB / MESO competitors research us, page-47

Thanks for your reply, @LeftYahoo.

I agree there will be enormous pressure for off-label use given the high likelihood of effectiveness given Rem-L mechanism of action has nothing to do with the COVID-19 virus, rather the cytokine storm suppression, common in ARDS of all types of viral and bacterial infections.

I can imagine an EAP initially, followed by some negotiations between FDA and MSB on what they will consider an appropriate study design and size to supplement the C-19 study. They will both have to rely heavily on the literature and evaluation of the mechanism of action to make sensible decisions to expedite an early approval with the "least burdensome approach":

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles